Various metabolic processes take place in the intestine and fall into two basic categories: metabolic processes that involve hydroelectric interchanges between lumen, tissue fluids and blood, as well as the absorption of terminal fractions of the various primary metabolic processes (glucides, proteids, and lipids), or reabsorption of substances relating to the enterohepatic circulation involving detoxication processes (e.g. bile salts); and, metabolic processes that regulate the production of toxic factors and systems responsible for their elimination. Particularly important because of their toxic potential is the production of ammonium radicals (which are extremely harmful to cerebral structures) as terminal processes of nitrogenated metabolism and the production of potentially carcinogenic substances, etc. The intestinal bacterial flora perform a role of enormous importance in the numerous biochemical processes that take place in the intestine. The bio-enzymatic activities of this flora bring about important metabolic modifications of the substrates with which they come into contact.
Gastrointestinal bacterial flora degrade a number of food substrates that cannot be attacked or digested by the digestive enzymes of the organism.
Responsibility for many of the events that are toxic for the organism and responsibility for the phenomena that lie at the basis of aging is attributed to the formation of free radicals, ubiquitous in various tissues of the organism. The formation of free radicals in the colon is particularly marked resulting from biological intervention of the intestinal bacterial flora.
A balance between the production of free radicals and anti-oxidant biological mechanisms is vital for maintenance of a state of health. Ideally, an increase in the production of free radicals ought to be matched by an increase in the processes of detoxication. Instead, aging results in a reduction in the efficiency of these processes. Numerous research studies have been dedicated to the development of probiotic products capable of regulating the activity of the gastrointestinal tract when alterations occur in resident bacterial flora; most commonly caused by: antibiotic usage, excessive sugar and yeast, stress, and processed foods. These products are intended to colonize the gastrointestinal tract with flora and prevent colonization of pathogenic bacteria (e.g. Candida albicans). Their mechanism of action involves the production of lactic acid which creates an environment unfavorable to the overgrowth of potentially pathogenic fungi and bacteria (including putrefactive bacteria) and establishment of an aciduric flora
However, a number of difficulties have arisen concerning the various biological principles and preparations containing them pertaining to their gastroresistance and stability, elements that affect the culture or development of the active principle in the intestinal tract and its biological activities.
Indeed, various experimental evidence points to the fact that products lose microbial content prior to expiration and log losses occur with limited (even a few hours) exposure in an acidic-pH environment. Thus, both product shelf-life and gastric barrier acidity represent obstacles to an adequate intestinal microbial installation. The lactoproducing microorganisms (i.e., those producing lactic acid, L+) are most commonly used (e.g. mild ferments). They possess probiotic activity and documented tolerability since frequently they are xe2x80x9corthobioticxe2x80x9d flora, i.e., normal human flora. In view of this fact, it is an object of the present invention to introduce such microorganisms into man in higher quantities as integrators in order to prepare the organism to better meet physiological challenges (e.g., intense physical or intellectual activity, physiological cycles, etc.) or even pathological conditions, i.e., for prophylaxis.
The use of lactoproducing microorganisms and the production of commercial preparations containing such principles require optimal growth of the microorganism and biological activity in man.
Requisites for clinical efficacy include stability of the biological product in suitable conditions of preservation (possibly at room temperature), resistance to gastric acidity, and the capacity to promote intestinal growth of the microorganism, together with all the associated characteristic activities.